Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
NCT Number: NCT06294301
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of LP-005 (Dose 1) was administered intravenously.
A single dose of LP-005 (Dose 2) was administered intravenously.
A single dose of LP-005 (Dose 3) was administered intravenously.
A single dose of LP-005 (Dose 4) was administered intravenously.
A single dose of LP-005 (Dose 5) was administered intravenously.
A single dose of LP-005 (Dose 6) was administered intravenously.
A single dose of placebo was administered intravenously.
LP-005 (Dose 7) was administered multiple times intravenously.
LP-005 (Dose 8) was administered multiple times intravenously.
LP-005 (Dose 9) was administered multiple times intravenously.
Placebo was administered multiple times intravenously.
Time frame: Observation for 78 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Time frame: Observation for 78 days after administration
The time when the blood drug concentration reaches its peak after a single dose of medication.
Time frame: Observation for 78 days after administration
The maximum concentration of LP-005 in the bloodstream after administration.
Time frame: Observation for 78 days after administration
The time required for the concentration of LP-005 in the bloodstream to decrease by half.
Time frame: Observation for 78 days after administration
The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration.
Time frame: Observation for 78 days after administration
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Time frame: Observation for 78 days after administration
The proportion of anti drug antibody (ADA) positive subjects at different detection time points.
Time frame: Observation for 78 days after administration
Evaluate complement C5 hemolytic activity and serum concentration of C5 changes from baseline at various time points of assessment.
Time frame: Observation for 78 days after administration
Evaluate C3b deposition on red blood cells and serum concentration of C3b changes from baseline at various time points of assessment.
Longbio Pharma
Industry
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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